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Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration.

Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.

Study design in IDA Trial 31,2

IDA Trial 3 was a randomized (1:1), multicenter, double-blind, safety study of FERAHEME 2 x 510 mg (n=997) vs ferric carboxymaltose 2 x 750 mg (n=1000) for the treatment of IDA in adult patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Both treatments were infused over at least 15 minutes. Most patients received their second infusion of FERAHEME or Injectafer® 7 (+1) days after the first infusion. The primary endpoint was to assess the incidence of moderate to severe hypersensitivity reactions (including anaphylaxis) or moderate to severe hypotension. Efficacy endpoints were the mean increase from baseline to Week 5 in Hgb per gram of iron administered, and mean change in Hgb from baseline to Week 5. An additional safety endpoint was a composite of the incidence of moderate to severe hypersensitivity reactions, serious cardiovascular events, and/or death. An additional endpoint was to determine the incidence of severe hypophosphatemia.

In IDA Trial 2, FERAHEME demonstrated non-inferiority to Venofer®* in raising Hgb levels ≥2.0 g/dL at any time from baseline to Week 52

Proportion of patients with Hgb increase of ≥2.0 g/dL at any time from baseline to Week 51

2.6%
difference*

(95% CI = -3.9% to 9.1%)
Non-inferiority margin : -15%2

*Venofer® is an iron replacement product indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD).3

Mean change in Hgb from baseline to Week 52,4

Study design in IDA Trial 21

The safety and efficacy of FERAHEME in adult patients with iron deficiency anemia, regardless of etiology, and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used, were assessed in a randomized, controlled clinical trial (IDA Trial 2) with FERAHEME administered as a rapid intravenous injection (prior method of administration that is no longer approved).

In IDA Trial 2, patients were randomized to treatment with FERAHEME or iron sucrose, FERAHEME (510 mg) and placebo were administered as 2 intravenous single-dose injections over 3-8 days, and iron sucrose (200 mg) was administered as 5 intravenous injections or infusions over a period of 14 days.

In IDA Trial 1, 81% of FERAHEME-treated patients experienced an increase in ≥2 g/dL Hgb at any time from baseline to Week 51,2

75.6%
difference*

(95% CI = 71.2% to 80.0%)

In IDA Trial 1, fatigue-related symptoms and impacts were assessed with FACIT-Fatigue*

After 5 weeks, FERAHEME-treated patients reported greater improvement from baseline in fatigue score than did patients in the placebo arm1,2

4.9 points
difference*

(95% CI = 3.08 to 6.71)

*Score range from 0 to 52 with higher scores indicating less fatigue.

Study design in IDA Trial 11

The safety and efficacy of FERAHEME in adult patients with iron deficiency anemia, regardless of etiology, and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used, were assessed in a randomized, controlled clinical trial (IDA Trial 1) with FERAHEME administered as a rapid intravenous injection (prior method of administration that is no longer approved).

In IDA Trial 1, patients were randomized to treatment with FERAHEME or placebo.

In an extension trial, FERAHEME demonstrated consistent efficacy across multiple courses of therapy

Hgb at treatment period baseline and treatment period Week 5 by treatment course3

Overall, 61&percnt; of ferumoxytol-treated patients did not require a second course of treatment over the 6-month study period3

95&percnt; confidence interval (CI) and p-value are from the paired t-test.

Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration.

Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.

Indication and Dosing

Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

who have intolerance to oral iron or have had unsatisfactory response to oral iron or

who have chronic kidney disease (CKD)

The recommended dose of FERAHEME is an initial 510 mg dose followed by a second 510 mg dose as early as 3 days and up to 8 days later, each dose infused over at least 15 minutes while the patient is in a reclined or semi-reclined position.

Contraindications

Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components or a history of allergic reaction to any intravenous iron product.

Warnings and Precautions

Hypersensitivity: In addition to the fatal and serious adverse reactions in the Boxed Warning, other adverse reactions associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). Allergic reactions have occurred following the first dose or subsequent doses in patients in whom a previous dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering Feraheme to these patients. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes.

Hypotension: Feraheme may cause clinically significant hypotension. Monitor patients for signs and symptoms of hypotension following each Feraheme administration.

Iron Overload: Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral iron therapy. Do not administer Feraheme to patients with iron overload.

Magnetic Resonance (MR) Imaging Test Interference: Administration of Feraheme may transiently affect the diagnostic ability of MR imaging. Alteration of MR imaging studies may persist for up to 3 months following the last Feraheme dose. Maximum alteration of vascular MR imaging is anticipated to be evident for 1 – 2 days following Feraheme administration.

You may report an adverse event related to AMAG Pharmaceuticals’ products by calling 1-877-411-2510 or emailing amag@druginfo.com. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.